In the first 18 months of the project, considerable progress has been made across various Work Packages (WPs).
WP1: The administrative and management structures and processes to be followed during the project have been established, including a Joint Controller Agreement, a Data Management Plan and the project’s Ethical Management Responsibilities. The 1st Policy Brief “Challenges and recommendations for research security: Learning from research ethics and integrity” has been published. The Dissemination and Communication Plan has been developed and implemented, while the project’s visibility within the European research community has been established through various campaigns.
WP2: Current ethics reviews were evaluated via systematic mapping of the literature, focus groups and interviews with ethics review experts. Challenges, facilitators and barriers of the current ethics review process were identified: informed consent, privacy, security, and transparency, which are tightly related to technological advancements; a range of systemic, structural, capacity-related, and cultural barriers that hinder the effectiveness of RECs; adaptability of ethics review processes across contexts and disciplines; ethical guidelines lagging behind technological advancements; complexity in research ethics in the social sciences and humanities; lack of institutional support; need for RECs to provide advice to researchers. Recommendations were formulated to improve the ethics review and the quality of research.
WP3: Five innovative methodologies for ethics reviews have been created: 1) consultative ethics review; 2) narrative ethics scenario building; 3) embedded ethics advisor, 4) iterative ethics review, and 5) two-step informed consent. The methodologies were transferred to the contexts of RECs via pilot workshops, with participation of REC members from diverse academic backgrounds. Four pilot workshops took place in Athens, Greece; Coimbra, Portugal; Bonn, Germany; Split, Croatia. The results are currently being consolidated into an overall report, which will further serve as resource to improve the methodologies. Findings so far confirm that the project’s approach and methodologies have been positively received addressing needs beyond the improvement of methods.
WP4: Innovative training material to address new challenges in ethics reviews is currently being developed in 4 thematic areas: eIC, gene editing, organoids and AI. Guidance documents for RECs as well as Massive Open Online Courses (MOOCs) for both ethics experts and researchers, have been developed for eIC and gene editing. In parallel, the guidance documents and MOOCs on organoids and AI are under preparation.
WP5 focuses on identifying and promoting policy choices supporting the uptake and dissemination of novel ethics review approaches in the European Research Area. WP2 and WP3 findings were used to develop the Dialogue Event (DE) Design Document. DEs will be organized in the second half of the project, and will engage with researchers, policymakers, funding agencies, ethics experts, activists, and representatives of the EC. An analysis of the policy frameworks relevant to the topics of the DEs has been initiated.
